Abstract 702: Payor coverage for laboratory developed genomic testing, a looming challenge for pediatric precision cancer medicine

Abstract Introduction: Although genomic testing may inform medical decision making for pediatric cancers, inconsistent coverage and variable payment by insurers has made routine utilization in clinical practice challenging. Payer’s state insufficient evidence of clinical utility limits their evaluation of medical necessity for genomic testing. Adoption of changes to CPT coding may have furthered an uncertain reimbursement landscape for laboratories. A review of solid and CNS tumor cases sequenced through the Precision in Pediatric Sequencing (PIPseq) program at Columbia University Irving Medical Center (CUIMC) was conducted to describe clinical utility, coverage, and reimbursement for genomic testing. Methods: Laboratory developed matched tumor-normal whole exome, tumor transcriptome, or 450+ targeted gene panel sequencing was performed in a CLIA-certified laboratory at CUIMC. Claims were submitted April 2014-October 2024 based on CPT coding Pre 2020 (stacked Tier 1/2 Molecular Pathology CPT codes) and Post 2020 (limited Genomic Sequencing Procedure (GSP) CPT codes). Carriers were categorized into commercial, managed government (managed Medicaid), and government (Medicaid) plans and linked to clinical utility, defined as an alteration of diagnostic, prognostic, or therapeutic significance, to demonstrate medical necessity of genomic testing. All costs were covered by PIPseq. Results: Reimbursement/utility data were available for 226/303 tests; Pre 2020 (n=186), Post 2020 (n=40). Solid tumors (ST), n=135 (2020: Pre n=113, Post n=22); CNS tumors (CNS), n=91 (2020: Pre n=73, Post n=18). Clinical utility was demonstrated in 162 tests (72%): ST, n=87 (64%); CNS, n=75 (82%). RNAseq identified 43% of findings (ST, n=38). Findings of diagnostic (n=61: ST, n=39) or prognostic (n=54: CNS, n=31) significance were identified; 44 were denied coverage (ST, n=20) and 70 received partial coverage (ST, n=41) at an average rate of 57% of the service charge. Targetable alterations were identified in 49 patients; 25 received a matched targeted therapy (CNS, n=15), 8 were denied coverage (CNS, n=5) and 17 received partial coverage (CNS, n=10) at an average rate of 51% of the service charge. Medicaid did not provide coverage for testing (n=11). Commercial and managed government plans Pre 2020 (n=177) covered 42% of the service charge (median, 50%) whereas limited GSP codes Post 2020 (n=38) led to a 48% reduction in reimbursement with insurers covering 21% of the service charge (median, 0%) (t (213)=3.58, p=.001; eta2=.06). Conclusions: 72% of samples sequenced had a clinically impactful finding supporting the medical necessity of testing in pediatric solid and CNS tumors. Changes in CPT coding not reflected in updated payer coverage policies reduced insurance coverage by 48%. Revised reimbursement policies are needed to ensure equitable access to genomic testing that benefits most patients. Citation Format: Jennifer A. Oberg, Susan Hsiao, Mahesh Mansukhani, James H. Garvin, Darrell J. Yamashiro. Payor coverage for laboratory developed genomic testing, a looming challenge for pediatric precision cancer medicine [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 702.